Phase IIIa Study of OPF-310 Encapsulated Porcine Islet Cells to Evaluate Safety and Effectiveness in Adults Ages 35 to 65 with Unstable Type 1 Diabetes

What this Trial Is About

Researchers are evaluating OPF-310, which consists of encapsulated porcine islet cells for xenotransplantation, in adults with unstable Type 1 Diabetes Mellitus T1DM. This first-in-human study aims to assess the safety, tolerability, and effectiveness of OPF-310 transplantation and to determine the recommended Phase 2 dose RP2D. Eligible participants have experienced severe hypoglycemic episodes despite treatment with a closed loop system CLS for at least six months. Participants will receive OPF-310 in an open-label trial with ascending doses. Initially, three subjects will receive 6,000 islet equivalents IEQkg and three will receive 12,000 IEQkg, both followed by safety monitoring. Then, seven more subjects will receive the recommended Phase 2 dose determined from earlier results. A total of 13 patients will be transplanted with OPF-310. During the study, researchers will monitor participants for up to one year after transplant. They will assess outcomes such as reduction in severe hypoglycemic events, improvements in glucose control measured by continuous glucose monitoring CGM, insulin use, and HbA1c levels. Other evaluations include porcine C-peptide levels, psychological impact assessments, and hypoglycemia awareness. Safety and tolerability will also be closely observed throughout the study period.

A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus